Hospira Inc. A Pfizer Company Recalls

All product recalls associated with Hospira Inc. A Pfizer Company.

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Recall Summary

Total Recalls

12

Past Year

0

Class I (Serious)

2

Most Recent

Feb 2018

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–12 of 12 recalls

Labetalol Hydrochloride (Hospira) – Cracked Glass (2018)

Defective Container: Cracked glass at the rim surface of glass vials, covered by the stopper and crimp seal.

Class IIModerate

FDAFeb 20, 2018Nationwide• Hospira Inc. A Pfizer Company

Argatroban Injection (Hospira) – Impurity Specification Failure (2017)

Failed Impurities/Degradation Specifications; out of specification result for denitroquinoline-related impurity during three month time point

Class IIILow

FDAJul 6, 2017Nationwide• Hospira Inc., A Pfizer Company

Succinylcholine Chloride Injection (Hospira) – sterility concern (2017)

Lack of Sterility Assurance

Class II

Moderate

FDAJun 15, 2017PR• Hospira a Pfizer Company

Sodium Bicarbonate Additive Solution (Hospira) – sterility concern (2017)

Lack of Sterility Assurance

Class IIModerate

FDAJun 15, 2017PR• Hospira a Pfizer Company

Sodium Bicarbonate Injection (Hospira) – sterility concern (2017)

Lack of Sterility Assurance

Class IIModerate

FDAJun 15, 2017PR• Hospira a Pfizer Company

Potassium Phosphates Injection (Hospira) – sterility concern (2017)

Lack of Sterility Assurance

Class IIModerate

FDAJun 15, 2017PR• Hospira a Pfizer Company

Levophed Injection (Hospira) – Packaging Deviation (2017)

GMP Deviation; A foreign stopper was observed during packaging of a lot of product.

Class IIModerate

FDAMay 18, 2017Nationwide• Hospira Inc., A Pfizer Company

Metronidazole Injection (Hospira) – leaking bag (2017)

Lack of Sterility Assurance: customer report of leaking bag

Class IIModerate

FDAFeb 10, 2017Nationwide• Hospira Inc., A Pfizer Company

Vancomycin Injection (Hospira) – Particulate Matter Contamination (2017)

Presence of Particulate Matter: A hair was found stuck to the stopper of inside a single vial. The hair came in contact with the reconstituted drug product.

Class IHigh

FDAJan 24, 2017Nationwide• Hospira Inc., A Pfizer Company

Marcaine 0.25% Injection (Hospira) – Sterility Risk (2016)

Lack of Assurance of Sterility and Subpotent Drug: defect in glass vial prevented stopper from forming a seal allowing water to ingress and dilute the product causing it to be less than the labeled potency.

Class IIModerate

FDASep 16, 2016Nationwide• Hospira Inc., A Pfizer Company

Marcaine 0.5% Injection (Hospira) – Sterility Risk (2016)

Lack of Assurance of Sterility and Subpotent Drug: defect in glass vial prevented stopper from forming a seal allowing water to ingress and dilute the product causing it to be less than the labeled potency.

Class IIModerate

FDASep 16, 2016Nationwide• Hospira Inc., A Pfizer Company

Bupivacaine (Hospira) – Particulate Matter (2016)

Presence of particulate matter: Confirmed customer report for the presence of particulate matter within a single vial.

Class IHigh

FDAAug 4, 2016Nationwide• Hospira Inc., A Pfizer Company

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Hospira Inc. A Pfizer Company Recalls

Recall Summary

Labetalol Hydrochloride (Hospira) – Cracked Glass (2018)

Argatroban Injection (Hospira) – Impurity Specification Failure (2017)

Succinylcholine Chloride Injection (Hospira) – sterility concern (2017)

Sodium Bicarbonate Additive Solution (Hospira) – sterility concern (2017)

Sodium Bicarbonate Injection (Hospira) – sterility concern (2017)

Potassium Phosphates Injection (Hospira) – sterility concern (2017)

Levophed Injection (Hospira) – Packaging Deviation (2017)

Metronidazole Injection (Hospira) – leaking bag (2017)

Vancomycin Injection (Hospira) – Particulate Matter Contamination (2017)

Marcaine 0.25% Injection (Hospira) – Sterility Risk (2016)

Marcaine 0.5% Injection (Hospira) – Sterility Risk (2016)

Bupivacaine (Hospira) – Particulate Matter (2016)